{
  "meta": {
    "disclaimer": "Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. We may limit or otherwise restrict your access to the API in line with our Terms of Service.",
    "terms": "https://open.fda.gov/terms/",
    "license": "https://open.fda.gov/license/",
    "last_updated": "2026-08-13",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "cfres_id": "215911",
      "product_res_number": "Z-0040-2026",
      "event_date_initiated": "2025-08-18",
      "event_date_posted": "2025-10-03",
      "recall_status": "Open, Classified",
      "res_event_number": "97463",
      "product_code": "QWU",
      "k_numbers": [
        "K223074"
      ],
      "product_description": "EverPatch+, REF: 1044002, Permanent Scleral Reinforcement Matrix 1x5.0mm x 8.5 mm Shield/1 x 5.0mm x 6.5 mm Rectangle, STERILE VH202",
      "code_info": "All Lots/ UDI: G16010440020",
      "firm_fei_number": "3029772936",
      "recalling_firm": "CORNEAT VISION, LTD.",
      "address_1": "4, Ha-Sheizaf 4 Ha-Sheizaf",
      "city": "Ra'Anana",
      "country": "Israel",
      "reason_for_recall": "Reviewed complaints have identified that conjunctival wound dehiscence may result in early exposure of the surgical patch.",
      "root_cause_description": "Unknown/Undetermined by firm",
      "action": "On August 18, 2025, CorNeat Vision, Ltd. issued a \"Urgent: Medical Device Recall\" Notification to affected consignees via E-Mail. CorNeat ask consignees to take the following actions:\n\n1.\tReview inventory, Quarantine and Discontinue use of All Lots of the CorNeat EverPatch and/or EverPatch+. \n\n2.\tPlease discard any unused product. \n\n3.\tEyecare providers should continue to monitor patients who have had CorNeat EverPatch and/or EverPatch+ implanted at the follow-up frequency necessary to detect signs of wound dehiscence or conjunctival thinning/erosion. \n\n4. Patients should be instructed to seek prompt follow-up if they experience any signs or symptoms consistent with this complication.\n\n5.\tThis notice needs to be passed on to all those within your organization or to any organization where the product has been transferred.\n\n6.\tPlease fill in the MEDICAL DEVICE RECALL RETURN RESPONSE form at www.corneat.com/everpatch-recall or fill in the attached form and forward to CorNeat Vision by email to complaints@corneat.com .",
      "product_quantity": "180 units",
      "distribution_pattern": "Worldwide - US Nationwide distribution in the states of AZ, CA, CO, CT, DC, DE, FL, GA, ID, \tIL, IN, KS, MA, MD, MI, MN, MO, MT, NC, NY, OH, PA, SC, TN, TX, UT, VA, WA, WI and the countries of Japan, Israel, Argentina, Hong Kong.",
      "openfda": {
        "k_number": [
          "K223074"
        ],
        "device_name": "Prosthesis, Eyelid Spacer/Graft, Polymer",
        "medical_specialty_description": "Ophthalmic",
        "regulation_number": "886.3130",
        "device_class": "2",
        "registration_number": [
          "3010155661",
          "3006550126"
        ],
        "fei_number": [
          "3010155661",
          "3006550126"
        ]
      }
    }
  ]
}